LEADER 01438nam 2200349Ia 450 001 9910696917903321 005 20230902161951.0 035 $a(CKB)5470000002383716 035 $a(OCoLC)560600003 035 $a(EXLCZ)995470000002383716 100 $a20100319d1996 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aDemonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products$b[electronic resource] 210 1$aRockville, MD :$cU.S. Food and Drug Administration, Center for Biologics Evaluation and Research :$cCenter for Drug Evaluation and Research,$d[1996] 215 $a1 electronic resource 300 $a"April 1996." 320 $aIncludes bibliographical references. 517 1 $aFDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products 606 $aBiologicals$zUnited States 615 0$aBiologicals 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910696917903321 996 $aDemonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products$93143295 997 $aUNINA